Breast Implant Risks

Breast Implant Risks

Some of the difficulties and negative effects of breast implants are as follows:

– Implant issues, such as breast pain and nipple and breast feeling changes – Additional operations, with or without device removal (also see Implant Removal Options)
– Capsular contracture, scar tissue (capsule) that grows around the implant and compresses it.
– Breast implant linked rupture and deflation
-anaplastic large cell lymphoma (BIA-ALCL), a non-lymphoma Hodgkin’s type (cancer of the immune system)
– Connective tissue disorders, breast cancer, and infertility
– Generalized symptoms
– Breastfeeding – Child Effects – Implant Complications

The list below includes local problems and unfavourable outcomes that affect at least 1% of breast implant patients at any given time. To treat any of these, you may require non-surgical treatments or more procedures, and you should discuss any complications and necessary therapy with your doctor. These complications are listed alphabetically, not by frequency of occurrence.

Complication Description

Asymmetry: In terms of size, shape, or breast level, the breasts appear unequal.
Breast Ache
Nipple or breast discomfort
Atrophy of Breast Tissue
Skin thinning and contraction
Calcium Deposits/Calcification
Under the skin, there are hard lumps around the implant. These can be misdiagnosed as cancer after mammography, necessitating extra surgery.
Capsular Dilation
Tightening of the tissue capsule surrounding an implant, resulting in stiffness or hardening of the breast and, in severe cases, squeezing of the implant.
Chest Wall Deviation
The chest wall or the underlying rib cage looks to be distorted.
Deflation
Leakage of saltwater (saline) solution from a saline-filled breast implant, usually caused by a valve leak or a rip or cut in the implant shell (rupture), resulting in partial or complete implant collapse.
Delayed Wound Repair The incision site does not heal normally or heals slowly.
Extrusion
The skin deteriorates, and the implant emerges through it.
Hematoma
Blood collection around the surgery site. Swelling, bruising, and pain may occur. Hematomas are most common after surgery, but they can occur at any time the breast is injured. Small hematomas can be absorbed by the body, but larger ones may necessitate medical intervention, such as surgical draining.
Iatrogenic Injuries and Damage
Tissue or implant injury or damage as a result of implant surgery
Toxic Shock Syndrome is a type of infection.
This happens when wounds are polluted by germs like bacteria or fungi. Most surgical infections manifest within a few days to a week, however infection can occur at any time following surgery. If antibiotics do not cure the infection, the implant may need to be removed.
Inflammation/Irritation
The body’s reaction to an infection or injury. Redness, swelling, warmth, soreness, and/or loss of function are all symptoms.
Lymphedema, also known as lymphadenopathy
Lymph nodes that are swollen or enlarged
Malposition/Displacement
The implant is not properly positioned in the breast. This can occur during or after surgery if the implant moves or shifts from its intended placement. Factors like as gravity, trauma, or capsular contracture can all induce shifting.
Necrosis
Skin or tissue that has died around the breast. Infection, the use of steroids in the postoperative breast pocket, smoking, chemotherapy/radiation, and severe heat or cold therapy can all lead to necrosis.
Changes in Nipple/Breast Sensation
An increase or reduction in nipple and/or breast sensation. Can vary in severity and be either temporary or permanent. It may have an impact on sexual response or breast feeding.
Palpability
The implant is palpable through the skin.
Ptosis
Breast sagging is commonly caused by normal age, pregnancy, or weight reduction.
Redness/Bruising
Bleeding during surgery might cause the skin’s colour to alter. This is a common side effect of surgery and is most likely transitory.
Rupture
A tear or hole in the outer shell of the implant.
Seroma
Fluid accumulation surrounding the implant. Swelling, discomfort, and bruising may occur. Small seromas may be absorbed by the body. Larger ones will necessitate the use of a surgical drain.
Rash on the Skin
A rash on or near the breasts.
Unsatisfactory Style/Size Because of the style or size of the implant chosen, the patient or doctor is dissatisfied with the overall appearance.
Visibility
The implant is visible through the skin.
Wrinkling/Rippling
Implant wrinkles that may be felt or seen through the skin.
The patient labelling for approved breast implants, Labeling for Approved Breast Implants, contains a comprehensive list of problems as well as information on the rates of certain complications.

Additional Operations
Breast implants are not regarded to be long-term devices. The longer patients have them, the more likely it is that they will develop complications, some of which will necessitate additional surgery. There is no certainty that any reoperation will result in a good cosmetic outcome.

The type of surgical procedure used during a reoperation is determined on the complication. Over the course of your life, you may require one or more reoperations due to a single issue or a combination of local difficulties. A single reoperation may include more than one technique. The following surgical techniques may be performed during a reoperation:

Removal of implants, with or without replacement
Capsule removal or surgical scar tissue release around the breast implant
Scar or wound revision, such as surgical scar tissue removal
Hematoma drainage involves putting a needle or tube through the skin to drain the blood accumulation. Implant repositioning involves surgically opening the incision and relocating the implant.
Biopsy/cyst removal is accomplished by introducing a needle through the skin or by cutting through the skin to remove a bulge.


Options for Implant Removal
There are two basic ways for implant removal if you choose to have your breast implants removed or if it is medically necessary. Your plastic surgeon may decide to remove only your implant and leave the scar tissue that surrounds it in your body, known as the scar capsule. This method necessitates less surgical dissection and may be associated with a lower risk of local problems such as haemorrhage. Alternatively, when your breast implant is removed, your surgeon may surgically remove the scar capsule. En-bloc resection is the term for this procedure. You should consult with your surgeon to determine which procedure is appropriate for your condition.

If you have any BIA-ALCL symptoms, such as persistent swelling or pain, or any changes in the area around your breast implant, consult your surgeon or health care provider about the need for additional testing. A physical exam, imaging, and/or examination of the fluid or tissue surrounding the breast implant are commonly used to diagnose BIA-ALCL. It is critical to undergo a BIA-ALCL evaluation since a verified BIA-ALCL diagnosis may modify the type of operation that should be performed.

Patients with verified BIA-ALCL need generally undergo implant removal as well as excision of the surrounding scar capsule, which is a more comprehensive procedure than implant removal alone. Consult your surgeon about the best way of removal for you.

One sort of reoperation is the removal of a breast implant, with or without replacement. The lifespan of breast implants varies from person to person and cannot be predicted. Because of one or more local issues, you may need to have your implant removed at some point throughout your life.

Some women prefer not to replace their implants after they have been removed. Cosmetically, these women may have dimpling, chest wall concavity, puckering, or sagging of their natural breasts.

The image below depicts a 29-year-old lady 1 year after her silicone gel-filled breast implants were removed but not replaced. Women who have big breast implants, particularly those placed on top of the chest muscles (subglandularly), may experience significant cosmetic deformities if they do not replace them or undergo subsequent reconstructive surgery.

In an augmentation patient, the implant is removed without replacement.
Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto, provided the photo.

Even if there are issues and even if the first implant procedure was covered, some insurance companies will not fund implant removal or replacement.

Capsular Dilation
The hardening of the breast surrounding the implant is known as capsular contracture. It can happen in the tissue that surrounds one or both implants. The tissue tightens as a result of the hardening, which can be uncomfortable.

Capsular contracture is more common after an infection, hematoma, or seroma. The reason of capsular contracture, on the other hand, is unknown.

Baker grades are the four levels of capsular contracture.

Baker Scale of Grading

Grade I: The breast is usually supple and appears natural.
Grade II: Breast is little firm but appears normal.
Grade III: The breast is hard and appears unnatural.
Breast is hard, uncomfortable, and appears abnormal in grade IV.


Capsular contracture in grades III and IV is considered severe and may necessitate reoperation. The surgical treatment often entails implant removal with or without implant replacement. There is a chance that capsular contracture can reoccur following surgery to correct it.

The FDA has not certified or approved any devices for the treatment or prevention of capsular contracture.

The image below depicts a Grade IV capsular contracture in a 29-year-old woman’s right breast 7 years after silicone gel-filled breast implants were placed.

Capsular contracture in a patient undergoing augmentation
Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto, provided the photo.

Deflation and Rupture
A rupture is a tear or hole in the breast implant’s outer shell.

Some of the possible reasons of breast implant rupture include:

Capsular constriction
During a mammography, compression occurs.
Surgical tool damage
Breast operations such as biopsies and fluid draining might cause damage.
Implant ageing is normal.
Saline-filled breast implants that are either overfilled or underfilled
Trauma or extreme physical pressure are examples of physical stresses.
Placement through an unapproved incision site, such as the belly button
Excessive handling during surgery
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Breast Implant Rupture and Deflation from Saline
The phrase rupture refers to all types of breast implants, whereas the term deflation refers specifically to saline-filled implants. You and/or your doctor will be able to detect if your saline-filled implant ruptures because the saline solution leaks into your body and deflates the implant instantly or over time. You will notice that your implant has shrunk in size or shape.

Because they are known to induce rupture and deflation, the following surgical procedures are not recommended for FDA-approved saline-filled breast implants:

Closed capsulotomy is a procedure for relieving capsular contracture that involves manually compressing the breast to rupture the stiff capsule.
Other than sterile saline, medicines or other substances may be placed inside the implant.
Any interaction with Betadine, a povidone-iodine topical antiseptic manufactured by Purdue Frederick Company
Through the implant shell injection
Changes to the implant
The implants are stacked (more than one implant per breast pocket).
The image below shows a 30-year-old woman with a deflated left saline-filled breast implant. The implant is assumed to have deflated due to a design that the manufacturer no longer uses.

Deflation in a patient undergoing augmentation.
Walter Peters, Ph.D., M.D., F.R.C.S.C., University of Toronto, provided the photo.

Rupture of a Silicone Gel-Filled Implant
Silicone breast implants can burst at any time following surgery, but the longer an implant is in place, the more likely it will rupture.

If a silicone gel-filled breast implant ruptures, it is unlikely that you or your doctor would detect right away because most silicone implant ruptures are “silent ruptures,” meaning they create no symptoms. A quiet rupture does not alter the appearance or feel of an implant, and your surgeon or health care provider may not be able to discover one through physical examination alone. The most efficient method for identifying silent rupture of silicone gel-filled breast implants is magnetic resonance imaging (MRI).

However, a woman may have a decrease in breast size, a change in breast implant shape, hard lumps over the implant or chest area, an uneven appearance of the breasts, pain or tenderness, tingling, swelling, numbness, burning, or changes in feeling if a silicone gel-filled implant ruptures.

When silicone gel-filled implants break, the silicone gel usually escapes through a tear or hole in the implant shell but remains restricted within the scar tissue capsule around the implant, a condition known as an intra-capsular rupture. An extracapsular rupture occurs when the gel migrates beyond the scar tissue surrounding the breast implant. Extracapsular rupture with gel migration occurs when the gel moves to other distant parts of the body following a rupture. After a rupture, it may be difficult to remove silicone gel.

Breast Cancer, Connective Tissue Disease, and Reproductive Issues
The FDA has found no link between silicone gel-filled breast implants and connective tissue illness, breast cancer, or fertility issues. However, the FDA has received reports of systemic symptoms (see below) in patients who have had both saline and silicone gel-filled breast implants. To properly comprehend these complexities, larger and longer research than those undertaken thus far are required.

[Breast Implant Illness (BII)] Systemic Symptoms
Breast implants may cause symptoms such as fatigue, memory loss, rash, “brain fog,” and joint discomfort. Some patients may refer to these symptoms as “breast implant sickness” (BII). Researchers are looking into these symptoms to learn more about their causes. These symptoms, as well as the reasons of them, are poorly understood. Breast implant removal without replacement has been reported to reverse symptoms of breast implant sickness in some situations.

We encourage patients to report any injury, adverse event, or symptom associated to a medical device to the FDA by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting programme, including the symptoms described above. Please give the following details:

Name of the device (Brand Name)
Name of the Manufacturer
Adverse Event Information and Medical and/or Surgical Interventions (if applicable)
Anaplastic Large Cell Lymphoma Caused by a Breast Implant (BIA-ALCL)
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a type of T-cell lymphoma that can develop as a result of breast implants. See Breast Implant-Associated Anaplastic Large Cell Lymphoma for more details (BIA-ALCL).

Understanding the Preferences of Patients
Patients’ opinions, preferences, and voices are crucial to understanding the impact medical devices have on their diseases and quality of life. The FDA’s Center for Devices and Radiological Health (CDRH) has announced plans to investigate how patients weigh the benefits and risks of smooth and textured breast implants, including the risk of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which occurs more frequently in patients with textured breast implants.

CDRH has contracted with Research Triangle Institute (RTI) International to undertake this study in September 2020. CDRH and RTI built the survey questionnaire using feedback from focus groups made up of individuals considering or having had breast reconstruction or augmentation utilising breast implants, as well as input from health care providers, to ensure the study prioritised the needs and experiences of patients.

The survey results, according to CDRH, will aid in determining if patients’ perceptions of the risks of BIA-ALCL associated with textured breast implants are altered by information on the potential benefits of textured breast implants.

The knowledge gathered from this patient-centered approach will aid in the incorporation of patient preferences into CDRH regulatory decision-making. CDRH is aiming to publish the findings of this study in a peer-reviewed journal. We will continue to keep the public informed when new information becomes available.

Breastfeeding
Some women who have breast augmentation can nurse effectively, while others cannot. Women who have mastectomies followed by breast implant reconstruction procedures may be unable to breastfeed on the damaged side due to loss of breast tissue and milk-producing glands.

Children’s Reactions
At this time, it is unknown whether a little quantity of silicone from the breast implant silicone shell may enter into breast milk during lactation. Although there are no proven methods for properly detecting silicone levels in breast milk, a study assessing silicon (one component of silicone) levels in breast milk found no greater amounts in breast milk from women with silicone gel-filled implants compared to women without implants.

Furthermore, concerns have been expressed about the possible harm to infants born to moms who have implants. Two human investigations discovered no higher risk of birth abnormalities in children delivered to mothers who had breast implant surgery. Although low birth weight was found in a third trial, this finding could be explained by other factors (for example, lower pre-pregnancy weight).